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Sign in to claim this brandAbbott
US
Last updated May 30, 2026
What Abbott makes
The company produces in vitro diagnostic (IVD) laboratory instruments and software, including analysers for spectrophotometry and chemiluminescent immunoassays, as well as related reagents and kits for testing hepatitis A, hepatitis B, and gamma-glutamyltransferase (GGT). It also manufactures single-use cardiac mapping catheters for percutaneous procedures and buffered sample diluents for diagnostic use, alongside glucose and carbon dioxide (CO₂) testing kits.
These products are regulated under Class I and Class II classifications in the US, with some devices exempt from classification (N). They are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their authorised status for commercial distribution in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- abbott.com
- —
- —
- [email protected]
- Phone
- +1(650)681-3470
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080174723
Catalogue (690)
Page 2 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alinity | 07P991A | FDA UDI | Class I | Active |
| Architect | 3L52-37 | FDA UDI | Class II | Unknown |
| Architect | 08K4128 | FDA UDI | Class I | Active |
| Alinity | 07P571A | FDA UDI | Class I | Active |
| Alinity | 08P5021 | FDA UDI | Class II | Active |
| Alinity | 09P2820 | FDA UDI | Class II | Active |
| Alinity | 08P501A | FDA UDI | Class I | Active |
| Alinity | 06P0820 | FDA UDI | N/A | Active |
| Alinity | 08P551C | FDA UDI | Class I | Active |
| Alinity | 01R5104 | FDA UDI | Class I | Active |
| Alinity | 09P451A | FDA UDI | Class I | Active |
| Alinity | 07P532A | FDA UDI | Class I | Active |
| Alinity | 04U7206 | FDA UDI | Class II | Active |
| Alinity | 08P5101 | FDA UDI | Class II | Active |
| Alinity | 07P5720 | FDA UDI | Class II | Active |
| Alinity | 04V5121 | FDA UDI | Class I | Active |
| Alinity | 07P771C | FDA UDI | Class I | Active |
| Architect | 08K2602 | FDA UDI | Class II | Active |
| Alinity | 09P915A | FDA UDI | Class I | Active |
| Architect | 02K4511 | FDA UDI | Class I | Active |
| AlinIQ | 03R89-62 | FDA UDI | Class I | Active |
| Alinity | 09P4620 | FDA UDI | Class II | Active |
| Alinity | 09P611A | FDA UDI | Class I | Active |
| Alinity | 09P2810 | FDA UDI | Class I | Active |
| Alinity | 09P523B | FDA UDI | Class I | Active |
| Alinity | 06P0403 | FDA UDI | N/A | Active |
| Alinity | 08P4320 | FDA UDI | Class II | Active |
| Alinity | 07P761A | FDA UDI | Class I | Active |
| Alinity | 06P025A | FDA UDI | N | Active |
| Architect | 08K2828 | FDA UDI | Class II | Active |
| Alinity | 04T7510 | FDA UDI | Class I | Active |
| Architect | 2P54-01 | FDA UDI | Class II | Active |
| Alinity | 08P2821 | FDA UDI | Class II | Active |
| Alinity | 09P631A | FDA UDI | Class I | Active |
| Alinity | 08P591B | FDA UDI | Class I | Active |
| Alinity | 09P581A | FDA UDI | Class I | Active |
| Architect | 1E04-42 | FDA UDI | Class II | Unknown |
| Architect | 3L80-32 | FDA UDI | Class II | Active |
| Alinity | 07P7330 | FDA UDI | Class I | Active |
| Alinity | 08P591A | FDA UDI | Class I | Active |
| Alinity | 09P281A | FDA UDI | Class I | Active |
| Architect | 2P13-01 | FDA UDI | Class I | Active |
| Alinity | 04U091A | FDA UDI | Class I | Active |
| Alinity | 07P5520 | FDA UDI | Class II | Active |
| Alinity | 07P7520 | FDA UDI | Class I | Active |
| Alinity | 01R071A | FDA UDI | Class I | Active |
| Alinity | 06P0603 | FDA UDI | N/A | Active |
| Alinity | 08P041B | FDA UDI | Class I | Active |
| Architect | 1E64-03 | FDA UDI | Class II | Active |
| Architect | 01P3024 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- ABBOTT GmbH Wiesbaden Hesse · DE FEI 3002809144